XLIMus drug eluting stent: A randomIzed controlled Trial to assess endothelialization. The XLIMIT trial.
Clinical trials
Coronary artery disease
Drug-eluting stent
Journal
International journal of cardiology. Heart & vasculature
ISSN: 2352-9067
Titre abrégé: Int J Cardiol Heart Vasc
Pays: Ireland
ID NLM: 101649525
Informations de publication
Date de publication:
Jun 2019
Jun 2019
Historique:
received:
18
03
2019
accepted:
15
04
2019
entrez:
8
5
2019
pubmed:
8
5
2019
medline:
8
5
2019
Statut:
epublish
Résumé
Thin strut 3rd generation drug eluting stents offer the potential advantage over the previous generation of better technical performance and reduced neointimal proliferation parameters, which are linked to mid and late term device failure. To evaluate the performance of the Xlimus sirolimus-eluting stent (SES) against the Synergy everolimus-eluting stent (EES) in terms of device reendothelialization in patients undergoing PCI for coronary artery disease (CAD). XLIMIT is a multicenter randomized controlled trial targeting 180 patients requiring percutaneous coronary interventions (PCI). Patients will be treated with Xlimus SES or Synergy EES implantation and randomization will be performed in a 2:1 ratio. The primary endpoint will be the reendothelialization grade of the Xlimus stent in terms of strut coverage and neointimal hyperplasia volume as compared to Synergy. Secondary endpoints will be represented by clinical and procedural outcomes. The first patient was enrolled on February 2019. A clearer understanding of the endothelialization process of new generation DES could significantly impact the treatment with dual antiplatelet therapy in the future. Moreover, although not powered for clinical end-points, the XLIMIT trial will provide randomized data in a population with minimal exclusion criteria. ClinicalTrials.gov Identifier: NCT03745053. Registered on November 19, 2018.
Sections du résumé
BACKGROUND
BACKGROUND
Thin strut 3rd generation drug eluting stents offer the potential advantage over the previous generation of better technical performance and reduced neointimal proliferation parameters, which are linked to mid and late term device failure.
AIM
OBJECTIVE
To evaluate the performance of the Xlimus sirolimus-eluting stent (SES) against the Synergy everolimus-eluting stent (EES) in terms of device reendothelialization in patients undergoing PCI for coronary artery disease (CAD).
METHODS
METHODS
XLIMIT is a multicenter randomized controlled trial targeting 180 patients requiring percutaneous coronary interventions (PCI). Patients will be treated with Xlimus SES or Synergy EES implantation and randomization will be performed in a 2:1 ratio. The primary endpoint will be the reendothelialization grade of the Xlimus stent in terms of strut coverage and neointimal hyperplasia volume as compared to Synergy. Secondary endpoints will be represented by clinical and procedural outcomes. The first patient was enrolled on February 2019.
CONCLUSIONS
CONCLUSIONS
A clearer understanding of the endothelialization process of new generation DES could significantly impact the treatment with dual antiplatelet therapy in the future. Moreover, although not powered for clinical end-points, the XLIMIT trial will provide randomized data in a population with minimal exclusion criteria.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov Identifier: NCT03745053. Registered on November 19, 2018.
Identifiants
pubmed: 31061876
doi: 10.1016/j.ijcha.2019.100363
pii: S2352-9067(19)30074-0
pii: 100363
pmc: PMC6487315
doi:
Banques de données
ClinicalTrials.gov
['NCT03745053']
Types de publication
Journal Article
Langues
eng
Pagination
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